Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
Status: | Completed |
---|---|
Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/14/2019 |
Start Date: | October 6, 2014 |
End Date: | June 5, 2017 |
The overall goal of this project is to determine the influence of patient treatment and host
factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women
factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women
This study is a phase III randomized clinical trial. HIV-negative women who test positive for
TV at their routine gynecological exam at participating clinics will be referred to the
nurse/study coordinator to screen for eligibility, provide a description of the study, and
obtain written, informed consent (N=700). Subjects will undergo an audio computer assisted
self- interview (ACASI), and will self-collect vaginal swabs for Trichomonas testing by
InPouch and Nucleic Acid Amplification Test (NAAT), Gram stain testing, and a future
microbiome specimen. They will be randomized into one of two arms; metronidazole (MTZ) 2 g
single dose (CDC recommended treatment regimen) or MTZ 500 mg twice daily x 7-day dose (CDC
alternative treatment regimen). All enrolled women will be scheduled for a follow-up visit at
four weeks post treatment completion (window 3-13 weeks).
TV at their routine gynecological exam at participating clinics will be referred to the
nurse/study coordinator to screen for eligibility, provide a description of the study, and
obtain written, informed consent (N=700). Subjects will undergo an audio computer assisted
self- interview (ACASI), and will self-collect vaginal swabs for Trichomonas testing by
InPouch and Nucleic Acid Amplification Test (NAAT), Gram stain testing, and a future
microbiome specimen. They will be randomized into one of two arms; metronidazole (MTZ) 2 g
single dose (CDC recommended treatment regimen) or MTZ 500 mg twice daily x 7-day dose (CDC
alternative treatment regimen). All enrolled women will be scheduled for a follow-up visit at
four weeks post treatment completion (window 3-13 weeks).
Inclusion Criteria:
- female
- English speaking
- >= 18 years old
Exclusion Criteria:
- HIV-infected
- unable to provide informed consent
- pregnant
- breast feeding
- treated by their provider for Bacterial vaginosis (BV) at visit
We found this trial at
3
sites
Birmingham, Alabama 35233
Principal Investigator: Christina Muzny, MD
Phone: 205-975-3298
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Jackson, Mississippi 39213
Principal Investigator: Leandro Mena, MD
Phone: 601-937-2387
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New Orleans, Louisiana 70119
Principal Investigator: Stephanie N Taylor, MD
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